Leading researchers working on synthetic biology technologies and their applications gathered at the University of Edinburgh in May 2018 to discuss the latest challenges and opportunities in the field In addition to the potential socio-economic benefits of synthetic biology, they also examined the ethics and security risks arising from the development of these technologies Speakers from industry, academia and not-for-profit organisations presented their vision for the future of the field and provide guidance to funding and regulatory bodies to ensure that synthetic biology research is carried out responsibly and that it realises its full potential This report aims to capture the collective views and recommendation that emerged from the discussions that took place The meeting was held under the Chatham House Rule to promote open discussion; the findings and quotes included in the report are therefore not attributed The goal of the meeting was to identify research priorities and bottlenecks It also provided the opportunity to discuss how best to manage risk and earn public acceptance of this emerging and disruptive technologies

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Future Trends in Synthetic Biology-A Report.

Since the beginning of the 21st Century, synthetic biology has established itself as an effective technological approach to design and engineer biological systems. Whilst research and investment continues to develop the understanding, control and engineering infrastructural platforms necessary to tackle ever more challenging systems - and to increase the precision, robustness, speed and affordability of existing solutions - hundreds of start-up companies, predominantly in the US and UK, are already translating learnings and potential applications into commercially viable tools, services and products. Start-ups and SMEs have been the predominant channel for synthetic biology commercialisation to date, facilitating rapid response to changing societal interests and market pull arising from increasing awareness of health and global sustainability issues. Private investment in start-ups across the US and UK is increasing rapidly and now totals over $12bn. Health-related biotechnology applications have dominated the commercialisation of products to date, but significant opportunities for the production of bio-derived materials and chemicals, including consumer products, are now being developed. Synthetic biology start-ups developing tools and services account for between 10% (in the UK) and ∼25% (in the US) of private investment activity. Around 20% of synthetic biology start-ups address industrial biotechnology targets, but currently, only attract ∼11% private investment. Adopting a more networked approach - linking specialists, infrastructure and ongoing research to de-risk the economic challenges of scale-up and supported by an effective long-term funding strategy - is set to transform the impact of synthetic biology and industrial biotechnology in the bioeconomy.

Developing synthetic biology for industrial biotechnology applications.

Evolution of Business Models in Regenerative Medicine: Effects of a Disruptive Innovation on the Innovation Ecosystem.

https://www.pure.ed.ac.uk/ws/files/78954690/LyallTait_RP_2019_BeyondLimitsGovernance.pdf

Beyond the limits to governance: New rules of engagement for the tentative governance of the life sciences

This thesis concerns the influence of healthcare systems regulation on firm-level capabilities and affordable healthcare technologies. Regulatory change is highly contentious, critics arguing that regulatory changes interfere with the efficiency of the market, and advocates arguing that well designed regulatory changes make markets more efficient and ensure market outcomes are more equitable. To date, very few studies analyze the influence of regulatory change on the medical device industry, and its ability to manufacture and supply affordable healthcare technologies. 
To respond to this gap, this research employs the Sectoral Systems of Innovation (SSI) approach as a theoretical framework to analyze the influence of regulatory changes on industrial capabilities in medical device industries and affordable healthcare technologies in South Africa and the United Kingdom. A mixed-method approach, focusing on three cases of regulatory change, emphasised documentary analysis and questionnaire-guided interviews to collect primary and secondary data from different sources in the healthcare systems of the two study countries. 
Regulatory changes facilitated some firms to create new strategies and innovative capabilities. Regulatory changes enabled some firms to develop close collaborative linkages with external providers in search of competitive advantage and improved market positioning. One reactive regulatory change, in particular, illustrated negative influence on innovative capabilities. Smaller firms were at a particular disadvantage in adapting to regulatory change. In the South Africa case, the more stringent regulatory requirements made it hard for domestic suppliers to enter the supply chain and led to joint ventures mainly with multinational corporations. The thesis argues, with empirical evidence, that a more enabling and discriminating regulation that takes into consideration of firms’ technological capabilities can achieve intended goals more efficiently and effectively, than constraining and indiscriminate regulation.

Medical device regulations, industrial capabilities, and affordable healthcare technology development : case studies from the United Kingdom and South Africa

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Proportionate and adaptive governance of innovative technologies (PAGIT): A framework to guide policy and regulatory decision making

/pdf/regenerative-medicine-as-a-disruptive-technology-5874kdulga.pdf

Regenerative medicine as a disruptive technology: Implications for manufacturing and clinical adoption

Proportionate and Adaptive Governance of Innovative Technologies (PAGIT): Case Study: Responsible Governance of Innovative Technologies Summary Report and Final Report

Elizabeth Tait

Papers

Proportionate and adaptive governance of innovative technologies (PAGIT): A framework to guide policy and regulatory decision making

Regenerative medicine as a disruptive technology: Implications for manufacturing and clinical adoption

Proportionate and Adaptive Governance of Innovative Technologies (PAGIT): Case Study: Responsible Governance of Innovative Technologies Summary Report and Final Report